Field of the Invention
The invention relates to a connecting device for use in a medical fluid transfer arrangement, the connecting device comprising first and second generally cylindrical parts, the first part comprising a hollow piercing member comprising an inner channel and the second part comprising a bottle coupling member. The invention also concerns a method for applying the connecting device to a medical bottle.
Description of Related Art
A major problem in relation to drug preparation, drug administration or other similar handling of pharmaceuticals is the risk of medical and pharmacological staff being exposed to drugs or solvents which may escape into ambient air. The problem is particularly serious when hazardous drugs such as cytotoxins, antiviral drugs, antibiotics, and radiopharmaceuticals are concerned. It has been found that safety boxes according to the present technology often provide insufficient environmental protection. For example, cytotoxins can evaporate at room temperature. Safety boxes and cabinets according to the present technology are provided with filters for filtration of circulating and exhaust air. Conventional or HEPA (High-Efficiency Particulate Arresting) filters are able to trap aerosols and particles, but no evaporated substances. Furthermore, aerosols and other particles which are initially trapped in the filters can transform into their gas phase and be released into the ambient air. For these reasons, systems for handling and administrating drugs and other medical substances under improved safer conditions have been developed.
U.S. Pat. No. 4,564,054 (Gustaysson) discloses a fluid transfer device for preventing air contamination when transferring a substance from a first vessel to a second vessel. The device is attached or connectible to the vessel and comprises a first member, in which a piercing member, e.g. a needle, provided with a passage is enclosed. The first member has a sealing member, e.g. a membrane, through which the needle can be passed. The device further comprises a second chamber, which is detachably connectible to the first member and which also has a sealing member, e.g. a membrane. When the first and second members are connected to each other, the two sealing members are located in position with respect to each other so that they can be penetrated by the piercing member which is movable with respect to the sealing member.
The sealing members are liquid and gas-proof barriers having the ability of sealing tightly after penetration and retraction of the piercing member to prevent leakage of liquid, as well as gas components. In another system for handling drugs and other medical substances, International Patent Publication No. WO 99/27886 A1 (Fowles et al.) discloses a connector device for establishing fluid communication between a first container and a second container. The connector device has a first sleeve member with a first and second end. The first sleeve member has a first attaching member at the first end that is adapted to attach to the first container. The connector device further has a second sleeve member with a first and second end. The second sleeve member is combinable with the first sleeve member and movable with respect thereto from an inactivated position to an activated position, wherein the second sleeve member has a second attaching member at the second end adapted to attach the second sleeve member to the second container.
The connector device disclosed in WO 99/27886 A1 further comprises a first and second piercing member projecting from one of the first and second sleeve members for providing a fluid flow path from the first container to the second container. The connector device further provides a means for independently hermetically sealing the first and second members.
Still a further system for handling hazardous drugs is disclosed in US 2003/0070726 A1 (Andreasson et al). US 2003/0070726 A1 refers to a fluid transfer assembly comprising a bottle connector with a hollow piercing needle, a drug bottle with a bottle closure, and a neck element having locking members for irreversible coupling of the connector to the bottle neck. The neck element and the connector have means for irreversible interconnection and interacting guiding members for directing the hollow needle to penetrate the bottle closure at a predetermined angle when establishing a fluid transfer line through the connector and into the drug bottle. Despite the efforts that have been made so far in order to improve safety when handling hazardous substances, and in particular hazardous drugs, there is still a need for further improvement. An object of the invention is, therefore, to provide a connecting device in a fluid transfer arrangement allowing the use of longer transfer needles.